Two-piece knotless suture anchor

ABSTRACT

A suture anchor assembly includes a suture anchor and a suture anchor inserter. The anchor includes a flexible distal tip and a rigid proximal anchor body. The distal tip includes a transverse suture eyelet and a cavity formed in a proximal end of the tip. The anchor body includes a lumen extending between proximal and distal ends of the body. The anchor inserter includes a tubular outer shaft and an inner inserter slidably received therein. The anchor assembly is actuatable to move the anchor tip and inner shaft proximally while the outer shaft and anchor body remain in place, urging the proximal end of the anchor tip against the distal end of the anchor body. The proximal end of the tip is deformable to accommodate at least a portion of the distal end of the anchor body within the anchor tip cavity.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a division of co-pending U.S. application Ser. No.15/118,224, entitled TWO-PIECE KNOTLESS SUTURE ANCHOR, which is the U.S.national phase entry under 35 U.S.C. § 371 of International ApplicationNo. PCT/US2015/019175, filed Mar. 6, 2015, which in turn claims priorityto and benefit of U.S. Provisional Application No. 61/948,929, filedMar. 6, 2014, the contents of which are incorporated herein by referencein their entirety for all purposes.

BACKGROUND

Suture anchors are employed in surgical repair operations for fixing asuture in a desired location with respect to a patient's anatomy.Typically, one or more sliding knots are formed in the suture in orderto secure the suture to the anchor. However, tying of sliding knots canbe difficult and/or time consuming, especially in combination withevolving arthroscopic surgical procedures. Accordingly, there is anongoing demand for improved suture anchors and corresponding deliverysystems that do not rely upon sliding suture knots to secure the sutureto the anchor.

SUMMARY

In an embodiment, a suture anchor assembly is provided. The sutureanchor assembly includes a suture anchor and an anchor inserter. Thesuture anchor includes an elongated anchor body having a lumen extendingthere-through between a proximal end and a distal end along alongitudinal axis. The suture anchor further includes an anchor tiphaving a proximal end and a distal end, the anchor tip including aneyelet extending transversely there-through and a cavity formed in theproximal end of the anchor tip, where the tip is separate from theanchor body. The anchor inserter includes a tubular outer shaftextending between a proximal end and a distal end. The anchor inserterfurther includes an inner shaft slidably receivable within the outershaft and the anchor body lumen. The distal end of the inner shaft ismechanically engageable with the cavity of the anchor tip so as toposition the anchor tip distally of the anchor body. The inner shaft isproximally retractable while mechanically engaged with the anchor tip soas to urge the proximal end of the anchor tip against the distal end ofthe anchor body. The proximal end of the anchor tip is deformable toaccommodate receipt of at least a portion of the distal end of theanchor body within the cavity upon being urged proximally against thedistal end of the anchor body.

Further embodiments of the suture anchor assembly may include one ormore of the following, in any combination.

In an embodiment of the suture anchor, the proximal end of the anchortip deforms radially outward to circumferentially overlie the portion ofthe distal end of the anchor body received within the cavity.

In an embodiment of the suture anchor assembly, the anchor tip furtherincludes a plurality of slots extending distally from the proximal endof the anchor tip along the length of the cavity defining a plurality ofwings, where the plurality of wings deflect outward to accommodate theportion of the distal end of the anchor body received within the cavity.

In an embodiment of the suture anchor assembly, the proximal end of theanchor tip does not extend into the anchor body lumen upon being urgedproximally against the distal end of the anchor body.

In an embodiment of the suture anchor assembly, the cavity does notintersect the eyelet within the anchor tip.

In an embodiment of the suture anchor assembly, a diameter of the cavityat the proximal end of the anchor tip is less than a diameter of thedistal end of the anchor body.

In an embodiment of the suture anchor assembly, the mechanicalengagement between the distal end of the inner shaft and the cavity is abreak-away connection.

In an embodiment, the suture anchor assembly further includes a firstplurality of threads formed along an inner surface of the cavity and asecond plurality of threads extending proximally from the distal end ofthe inner shaft, the second plurality of threads adapted to mate withthe first plurality of threads. The first and second plurality ofthreads are disengageable from one another by stripping upon proximalretraction of the inner shaft with respect to the inner shaft by adistance sufficient to shear at least one of the first and secondplurality of threads and allow the first and second plurality of threadsto slip past one another.

In an embodiment, the suture anchor assembly further includes a sutureextending through the eyelet.

In an embodiment of the suture anchor assembly, the inner shaft does notengage the suture.

In an embodiment, a method of suture fixation is provided. The methodincludes providing a suture anchor assembly including a suture anchorand an anchor inserter. The suture anchor includes an elongated anchorbody having a lumen extending there-through between a proximal end and adistal end along a longitudinal axis. The suture anchor further includesan anchor tip having a proximal end and a distal end, the anchor tipincluding an eyelet extending transversely there-through and a cavityformed in the proximal end of the anchor tip, where the tip is separatefrom the anchor body. The anchor inserter includes a tubular outer shaftextending between a proximal end and a distal end. The anchor inserterfurther includes an inner shaft received within the outer shaft and theanchor body lumen. The distal end of the inner shaft is mechanicallyengaged with the cavity of the anchor tip so as to position the anchortip distally of the anchor body. The method further includes routing asuture through the eyelet, inserting at least a portion of the anchorinto a bone hole using the anchor inserter, and proximally retractingthe inner shaft with respect to the anchor body and the outer shaft soas to urge the proximal end of the anchor tip against the distal end ofthe anchor body. The proximal end of the anchor tip is deformable toaccommodate receipt of at least a portion of the distal end of theanchor body within the cavity upon being urged proximally against thedistal end of the anchor body.

Further embodiments of the method may include one or more of thefollowing, in any combination.

In an embodiment of the method, the proximal end of the anchor tipdeforms radially outward to circumferentially overlie the portion of thedistal end of the anchor body received within the cavity.

In an embodiment of the method, the anchor tip further includes aplurality of slots extending distally from the proximal end of theanchor tip along the length of the cavity defining a plurality of wings,where the plurality of wings deflect outward to accommodate the portionof the distal end of the anchor body received within the cavity.

In an embodiment, the method further includes disengaging the mechanicalengagement of the inner shaft to the cavity after deformation of theanchor tip to accommodate the portion of the distal end of the anchorbody received within the cavity.

In an embodiment of the method, the mechanical engagement between thedistal end of the inner shaft and the cavity is a break-away connectionand disengaging the mechanical engagement includes severing thebreak-away connection.

In an embodiment of the method, the inner shaft does not engage thesuture.

In an embodiment of the method, the proximal end of the anchor tip doesnot extend into the anchor body lumen upon being urged proximallyagainst the distal end of the anchor body.

In an embodiment, a suture anchor assembly is provided. The sutureanchor assembly includes a suture anchor and an anchor inserter. Thesuture anchor includes an elongated anchor body having a lumen extendingthere-through between a proximal end and a distal end along alongitudinal axis, the anchor body further including a first pair oflongitudinal channels formed on a surface of the lumen. The sutureanchor also includes an anchor tip having a proximal end and a distalend, the anchor tip being separate from the anchor body. The anchor tipfurther includes an eyelet extending transversely there-through, asuture bridge extending transversely there-through, a cavity formed inthe proximal end of the anchor tip, and a second pair of channels formedwithin the anchor tip, extending distally from the cavity and adjacentto the suture bridge. The anchor inserter includes a tubular outer shaftextending between a proximal end and a distal end and an inner shaftslidably receivable within the outer shaft and the anchor body lumen.The suture anchor assembly further includes a flexible member routedthrough the anchor assembly with the anchor tip positioned distally ofthe anchor body, where the flexible member bends around the suturebridge and free limbs of the flexible member extending from the bend areslidably received within a passageway formed by the first and secondpair of channels. The flexible member is proximally retractable whilerouted through the anchor assembly so as to urge the proximal end of theanchor tip against the distal end of the anchor body. The proximal endof the anchor tip is deformable so as to accommodate receipt of at leasta portion of the distal end of the anchor body within the cavity uponbeing urged proximally against the distal end of the anchor body.

Further embodiments of the suture anchor assembly may include one ormore of the following, in any combination.

In an embodiment of the suture anchor assembly, the proximal end of theanchor tip deforms radially outward to circumferentially overlie theportion of the distal end of the anchor body received within the cavity.

In an embodiment of the suture anchor assembly, the eyelet defines aplurality of wings in the proximal end of the anchor tip and theplurality of wings deflect outward to accommodate the portion of thedistal end of the anchor body received within the cavity.

In an embodiment of the suture anchor assembly, the suture bridge ispositioned at the distal terminus of the anchor tip and the second pairof channels extend through the distal terminus of the anchor tip.

In an embodiment of the suture anchor assembly, the suture bridge isproximally distanced from the distal terminus of the anchor tip and thepassageway further includes a transversely extending segment positioneddistally of the suture bridge and intersecting the second pair ofchannels for routing the flexible member around the suture bridge withinthe anchor tip.

In an embodiment, a method of suture fixation is provided. The methodincludes providing a suture anchor assembly including a suture anchorand an anchor inserter. The suture anchor includes an elongated anchorbody having a lumen extending there-through between a proximal end and adistal end along a longitudinal axis, the anchor body further includinga first pair of longitudinal channels formed on a surface of the lumen.The suture anchor also includes an anchor tip having a proximal end anda distal end, the anchor tip being separate from the anchor body. Theanchor tip includes an eyelet extending transversely there-through, asuture bridge extending transversely there-through, a cavity formed inthe proximal end of the anchor tip, and a second pair of channels formedwithin the anchor tip, extending distally from the cavity and adjacentto the suture bridge. The anchor inserter includes a tubular outer shaftextending between a proximal end and a distal end and an inner shaftslidably received within the outer shaft and the anchor body lumen. Thesuture anchor assembly also includes a flexible member routed throughthe anchor assembly with the anchor tip positioned distally of theanchor body, where the flexible member bends around the suture bridgeand free limbs of the flexible member extending from the bend areslidably received within a passageway formed by the first and secondpair of channels. The method further includes routing a repair suturethrough the eyelet, inserting at least a portion of the anchor into abone hole using the anchor inserter, and proximally retracting the innershaft and the free limbs of the flexible member with respect to theanchor body and the outer shaft so as to urge the proximal end of theanchor tip against the distal end of the anchor body. The proximal endof the anchor tip is deformable so as to accommodate receipt of at leasta portion of the distal end of the anchor body within the cavity uponbeing urged proximally against the distal end of the anchor body.

Further embodiments of the method may include one or more of thefollowing, in any combination.

In an embodiment of the method, the proximal end of the anchor tipdeforms radially outward to circumferentially overlie the portion of thedistal end of the anchor body received within the cavity.

In an embodiment of the method, the eyelet defines a plurality of wingsin the proximal end of the anchor tip and the plurality of wings deflectoutward to accommodate the portion of the distal end of the anchor bodyreceived within the cavity.

In an embodiment, the method further includes removing the flexiblemember, the inner shaft, and the outer shaft from the anchor.

In an embodiment of the method, the suture bridge is positioned at thedistal terminus of the anchor tip and the second pair of channels extendthrough the distal terminus of the anchor tip.

In an embodiment of the method, the suture bridge is proximallydistanced from the distal terminus of the anchor tip and the passagewayfurther includes a transversely extending segment positioned distally ofthe suture bridge and intersecting the second pair of channels forrouting the flexible member around the suture bridge within the anchortip.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages will beapparent from the following more particular description of theembodiments, as illustrated in the accompanying drawings in which likereference characters refer to the same parts throughout the differentviews. The drawings are not necessarily to scale, emphasis instead beingplaced upon illustrating the principles of the embodiments.

FIG. 1 is a schematic illustration of an embodiment of a suture anchorassembly including a two piece knotless suture anchor and correspondinganchor inserter, depicted in a cut-away side view;

FIGS. 2A-2B are schematic illustrations of the anchor assembly of FIG.1; (A) unactuated state; (B) actuated state;

FIG. 3A is a schematic illustration of another embodiment of a sutureanchor assembly including a two piece knotless suture anchor andcorresponding anchor inserter, depicted in cut-away side view;

FIG. 3B is a schematic illustration of the anchor assembly of FIG. 3A ina transverse cross-sectional view;

FIGS. 3C-3D are schematic illustrations of alternative embodiments ofthe anchor assembly of FIG. 3A in a transverse cross-sectional view; and

FIGS. 4A-4B are schematic illustrations of the anchor assembly of FIG.3A; (A) unactuated state; (B) actuated state.

DETAILED DESCRIPTION

There are a number of challenges faced in delivery of suture anchorassemblies for use in soft tissue to bone repair. One such challenge islocating the point at which the suture anchor is to be inserted into thebone. Often, suture anchors are inserted into the bone within apreviously prepared hole. While the general location of the bone hole isknown, it can be difficult to maintain the bone hole precisely alignedwith the delivery pathway of the anchor assembly given its relativelysmall size, as well as limited visibility within the surgical site.Accordingly, is desirable for a suture anchor assembly to possess thecapability to locate a bone hole within a defined area in which the holeis known to be located.

Another such challenge is maintaining a clear delivery pathway for thesuture anchor assembly to the bone hole. As the connections between thesoft tissue and bone in the region of the repair are weakened orsevered, soft tissue and bone can shift during surgery, blocking thedelivery pathway, requiring a surgeon to move portions of the patient'sanatomy. Accordingly, it is also desirable for a suture anchor assemblyto support the mechanical forces (e.g., moments, axial forces, shearforces, etc.) experienced if a surgeon were to use the suture assemblyto move soft tissue and/or bone.

Embodiments of the present disclosure describe suture anchors andcorresponding suture anchor inserters (collectively suture anchorassemblies) that satisfy these requirements. Further embodiments of thedisclosed suture anchor assemblies are employed without the use ofsuture knots. The disclosed suture anchor assemblies may be employed insurgical repair operations that include, but are not limited to, jointrepair (e.g., shoulder joint, knee joint), bone block fusion (e.g.,Latarjet), and the like, performed arthroscopically ornon-arthroscopically.

In an embodiment, suture anchor assemblies are provided that include asuture anchor and a suture anchor inserter. The anchor includes aflexible distal tip and a rigid proximal anchor body. The distal tipincludes a transverse suture eyelet and a cavity formed in a proximalend of the tip. The anchor body is fully cannulated, with a lumenextending between proximal and distal ends of the body. The anchorinserter includes a tubular outer shaft and an inner inserter slidablyreceived therein.

The anchor is mounted to the anchor inserter for delivery to a repairsite (e.g., a bone hole). For example, the inner shaft is receivedwithin the anchor body, with the proximal end of the anchor bodyadjacent to or contacting a distal end of the outer shaft. When theanchor is mounted to the anchor inserter, the anchor tip is alsopositioned distal to the anchor body, with a proximal end of the anchortip adjacent to or contacting the distal end of the anchor body. Priorto insertion within a patient, a suture is further placed within theanchor tip eyelet.

In use, the anchor is inserted (e.g., pounded) into a bone hole usingthe anchor inserter. Each of the components of the anchor assembly arefurther constrained in place with respect to one another until afterinsertion is complete. Beneficially, the anchor assembly design providesa number of advantages that address the challenges noted above,facilitating anchor delivery. In one example, the anchor is supported bythe inner shaft, providing mechanical durability that allows the surgeonto move soft tissue and/or bone with the anchor assembly. In anotherexample, the anchor tip is useable by a surgeon as a probe to tactilelyidentify the location of the bone hole.

Once the anchor is inserted into the bone hole, the anchor assembly isactuated such that the anchor tip and inner shaft are proximallyretracted while the outer shaft and anchor body remain in place, urgingthe proximal end of the anchor tip against the distal end of the anchorbody. As the anchor tip is flexible, relative to the anchor body, thismotion causes the proximal end of the tip to deform and accommodate atleast a portion of the distal end of the anchor body within the anchortip cavity. In addition to securing the anchor tip to the anchor body,this proximal activation of the suture anchor also results in lateralexpansion of at least a portion of the anchor tip against thesurrounding bone, further enhancing fixation of the anchor to the bone,After the anchor tip is proximal retracted by a desired distance, theanchor inserter is removed from the anchor, leaving the anchor andsuture secured to the bone.

Embodiments of a first suture anchor assembly 100 will now be discussedwith respect to FIGS. 1 and 2A-2B. The anchor assembly 100 includes ananchor 102 including an elongated anchor body 106 and an anchor tip 110,separate from the anchor body 106. The anchor assembly 100 furtherincludes an anchor inserter 104 including an outer shaft 114 and aninner shaft 116. Each of the components of the anchor 102 and anchorinserter 104 is discussed in detail below.

With regards to the anchor 102, the anchor body 106 is generallytubular, including a lumen 106A extending along a longitudinal axis 112between a proximal end and a distal end. In the embodiment of FIG. 1,the anchor body 106 further includes a plurality of tissue engagingfeatures 120 (e.g., a plurality of annular ribs) formed on an outersurface of the anchor body 106 for aiding fixation of the anchor withinbone. However, in alternative embodiments, the tissue engaging featuresmay include one or more of barbs, protrusions, threads, and the like. Infurther embodiments, the tissue engaging features may be omitted.

The anchor tip 110 is formed as a separate component from the anchorbody 106 and includes an internal cavity 110A and an eyelet 110B. Thecavity 110A is formed within the proximal end of the anchor tip 110 andextends a selected distance distally there-from. As discussed in greaterdetail below, the cavity 110A is further adapted to mechanically engagethe inner shaft 116. The eyelet 110B extends transversely throughopposing sides of the anchor tip 110 and is dimensioned for receipt of asuture. As illustrated in FIG. 1, the eyelet 110B is further positioneddistally of the cavity 110A, where the longitudinal extent of the cavity110A terminates proximal to the eyelet 110B and the cavity 110A does notintersect the eyelet 110B. As further discussed below, suchconfiguration inhibits interaction of the anchor inserter 104 (e.g., theinner shaft 116) with a suture positioned within the eyelet 110B.However, in alternative embodiments, the cavity may be connected withthe eyelet.

With regards to the anchor inserter 104, the outer shaft 114 isgenerally elongated and tubular. The inner shaft 116 also elongated,extending between proximal and a distal ends, and slidably receivedwithin both the outer shaft 114. Although not shown, in certainembodiments, the anchor inserter includes a handle at a proximal end,engaged to respective proximal ends of each of the outer and innershafts, allowing a user grasping the handle to manipulate the positionof the anchor inserter and a suture anchor mounted to the distal endthereof.

The inner shaft 116 is further adapted to move independently of theouter shaft 114. For example, the proximal end of the inner shaft maycommunicate with a user-actuatable mechanism, such as a trigger,allowing the inner shaft to be extended distally or retracted proximallywith respect to the outer shaft. In further embodiments, not shown, theproximal end of the inner shaft may engage a rotatable element (e.g., awheel, knob, etc.) mounted to the handle for rotation of the inner shaftwith respect to the outer shaft.

The inner shaft and outer shaft of the anchor inserter may be formedfrom any materials capable of performing the functions of the anchorinserter. Examples of such materials include, but are not limited to,plastics, metals, and composites. In further embodiments, the anchorinserter may be formed from biocompatible materials.

FIG. 1 further illustrates the anchor 102 mounted to the anchor inserter104 prior to use. The inner shaft 116 extends through the outer shaft114 and the anchor body lumen 106A. The anchor tip 110 is positioneddistally of the anchor body 106 and receives the distal end of the innershaft 116 within the cavity 110A. In the embodiment illustrated in FIG.1, the proximal end of the anchor body 106 is placed into contact withthe distal end of the outer shaft 114 and the proximal end of the anchortip 110 is placed into contact with the distal end of the anchor body106. However, in alternative embodiments, a gap may be present betweenat least one of the proximal end of the anchor body and the distal endof the outer shaft and the proximal end of the anchor tip and the distalend of the anchor body.

The distal end of the inner shaft 116 and the anchor tip 110 are alsoadapted for engagement to each other (e.g., via mechanical engagement122) when the anchor 102 is mounted to the anchor inserter 104. Forexample, the distal end of the inner shaft 116 and the cavity 110A areeach formed with mating engagement features. As illustrated in theembodiment of FIG. 1, the mechanical engagement 122 is a threadedfastening including a first plurality of threads formed along an innersurface of the cavity 110A and a second plurality of threads formedalong an outer surface of the distal end of the inner shaft 116. Thefirst and second plurality of threads are adapted to mate with oneanother when the distal end of the inner shaft 116 is inserted withinthe cavity 110A and rotated. The threads are disengaged from one anotherby unthreading the distal end of the inner shaft 116 from the cavity110A.

In further embodiments, the mechanical engagement may be a break-away orfrangible connection 126, where the anchor tip 110 and distal end of theinner shaft 116 are disengaged from one another by breaking themechanical engagement 122. For example, in the embodiment of FIG. 1, thefirst and second plurality of threads may be adapted to disengage fromeach other by stripping open. The inner shaft 116 is proximallyretracted by a distance sufficient to shear at least one of the firstand second plurality of threads, allowing the first and second pluralityof threads to slip past one another. In another example, the first andsecond plurality of threads may be adapted to disengage from one anotherby unscrewing the inner shaft 116 with respect to the anchor tip 110.

In alternative embodiments, the mechanical engagement may adopt otherforms and, optionally, mechanisms for providing breakaway functionality,as necessary. Examples may include, but are not limited to, mechanicalstops such as mating protrusions and sockets, frictional engagementspress-fits), thereto-press fit/heat stake, snap fit, thinned wallsections, and the like.

With further reference to FIGS. 2A-2B, the anchor assembly 100 isillustrated during use. A suture (not shown) is positioned within theeyelet 110B, where one or more free limbs of the suture extend outwardfrom the eyelet 110B. After the suture is positioned within the eyelet110B, at least a portion of the anchor 102 is inserted into a pre-formedbone hole within the patient's anatomy (not shown) using the anchorinserter 104. For example, the entire anchor may be inserted into thebone hole by pound in force directed to the anchor through the anchorinserter. During this insertion process, at least one of the free suturelimbs is positioned so as to be impinged between the anchor body and thewalls of the bone hole.

Beneficially, as discussed above, the anchor 102 is supported by theinner shaft 116, providing mechanical durability that allows the surgeonto move soft tissue and/or bone with the anchor assembly 100. In anotherexample, the anchor tip 110 is useable by a surgeon as a probe totactilely identify the location of the bone hole.

Until inserted into the bone hole, the components of the anchor assembly100 do not substantially move relative to one another. This isaccomplished by the mechanical engagement 122, which secures the anchortip 110 to the inner shaft 116 and, in turn, constrains axial motion ofthe anchor body 106. However, once the anchor assembly 100 has beenplaced in the bone hole, the inner shaft 116 is retracted proximally(arrow 204) with respect to the anchor body 106 and outer shaft 114.Owing to the engagement between the anchor tip 110 and the inner shaft116 provided by the mechanical engagement 122, the anchor tip 110 alsomoves proximally in response to this motion, causing the proximal end ofthe anchor tip 110 to be urged against the distal end of the anchor body106.

The anchor tip 110 and the anchor body 106 are configured such that,when the proximal end of the anchor tip 110 is urged against the distalend of the anchor body 106, the proximal end of the anchor tip 110deforms to accommodate receipt of at least a portion of the distal endof the anchor body 106 within the cavity 110A. Concurrently, the distalend of the anchor body 106 exhibits little to no deformation.

For example, in one embodiment, illustrated in FIGS. 2A-2B, thegeometric shape of the anchor tip 110 provides the desired deformationin the proximal end of the anchor tip 110. The anchor tip 110 includestwo slots 200 extending distally from its proximal end. In alternativeembodiments, not shown, different numbers of slots may be present (e.g.,one, three four, etc. The slots 200 define a plurality of wings 202there-between. When urging the proximal end of the anchor tip 110against the distal end of the anchor body 106 (FIG. 2A), the wings 202deflect outwardly from the anchor 100 (FIG. 2B), bending at hinge 202A.

As further shown in FIG. 1, embodiments of the anchor 100 may alsoinclude a tapered portion 124 on an inner surface of the cavity 110A.The tapered portion 124 narrows in thickness towards the proximalterminus of the anchor tip 110, widening the diameter of the cavity 110Atowards the proximal terminus of the anchor tip 110. This configurationimproves the ease with which the proximal end of the anchor tip 110deforms to accommodate the portion of the distal end of the anchor body106 received within the cavity 110A. It may be understood, however, thatthe tapered portion may be omitted in certain embodiments.

In another embodiment, the material from which the anchor tip and theanchor body are formed facilitate deformation of the proximal end of theanchor tip. For example, at least the proximal end of the anchor tip maybe formed from a material that substantially deforms, elastically orplastically, when urging the proximal end of the anchor tip against thedistal end of the anchor body. In one embodiment, the anchor tip may bemore flexible than the anchor body. For example, the anchor tip may beformed from a first material (e.g., a polymer, metal, metal alloy, etc)while the anchor body is formed from second, stiffer material (e.g., astiffer polymer, metal, metal alloy, etc.). In an embodiment, theproximal end of the anchor tip deforms radially outward tocircumferentially overlie the portion of the distal end of the anchorbody received within the cavity. Embodiments of the suture anchorassembly may employ such materials alone or in combination with one ormore of the geometric features discussed above to facilitate deformationof the proximal end of the anchor tip to accommodate receipt of at leasta portion of the distal end of the anchor body within the cavity.

FIGS. 3A-3B illustrate a second embodiment of the suture anchor assembly300. Similar to anchor assembly 100, the anchor assembly 300 includes ananchor 302 and an anchor inserter 304, where the anchor includes ananchor body 306 and anchor tip 310 and the anchor inserter 304 includesan inner shaft 316 and an outer shaft 314. However, as discussed indetail below, the anchor assembly 300 further includes a flexible member324 to constrain the anchor tip 310 in place with respect to the anchorbody 306 during insertion and to proximally retract the anchor tip 310into engagement with the anchor body 306. In certain embodiments, theflexible member 324 is a suture. However, in alternative embodiments,the flexible member 324 may include, but is not limited to, fishingstring, wires (e.g., plastic, metal), springs, and the like.

With regards to the anchor 302, the anchor body 306 is generallytubular, including a lumen 306A extending along a longitudinal axis 312between a proximal end and a distal end. In the embodiment of FIG. 3A,the anchor body 306 further includes a plurality of tissue engagingfeatures 320 (e.g., a plurality of annular ribs) formed on an outersurface of the anchor body 306 for aiding fixation of the anchor withinbone. However, in alternative embodiments, the tissue engaging featuresmay include one or more of barbs, protrusions, threads, and the like. Infurther embodiments, the tissue engaging features may be omitted.

The anchor tip 310 is formed as a separate component from the anchorbody 306 and includes a cavity 310A and an eyelet 310B. The cavity 310Ais formed within the proximal end of the anchor tip 310 and extendsdistally there-from. The eyelet 310B extends transversely through theanchor tip 310 and is dimensioned for receipt of a suture (e.g., arepair suture 404, as discussed below). For example, as illustrated inFIG. 3A, the cavity 310A and eyelet 310B intersect, with the sidewallsof the eyelet 310B including a taper 322 that narrows moving towards theproximal end of the anchor tip 310. This taper 322 facilitatesdeformation of the proximal end of the anchor tip 310 when urged againstthe distal end of the anchor body 306, as discussed below. In furtherembodiments, the taper may be omitted.

With regards to the anchor inserter 304, the outer shaft 314 isgenerally elongated and tubular. The inner shaft 316 also elongated,extending between proximal and a distal ends, and slidably receivedwithin both the outer shaft 314. Although not shown, in certainembodiments, the anchor inserter includes a handle at a proximal end,engaged to respective proximal ends of each of the outer and innershafts, allowing a user grasping the handle to manipulate the positionof the anchor inserter and a suture anchor attached to the distal endthereof.

The inner shaft 316 is further adapted to move independently of theouter shaft 314. For example, the proximal end of the inner shaft maycommunicate with a user-actuatable mechanism, such as a trigger,allowing the inner shaft to be extended distally or retracted proximallywith respect to the outer shaft. In further embodiments, not shown, theproximal end of the inner shaft may engage a rotatable element (e.g., awheel, knob, etc.) mounted to the handle for rotation of the inner shaftwith respect to the outer shaft.

Embodiments of the inner shaft and outer shaft of the anchor insertermay be formed from any materials capable of performing the functions ofthe anchor inserter. Examples of such materials include, but are notlimited to, plastics, metals, and composites. In further embodiments,the anchor inserter may be formed from biocompatible materials.

In an embodiment, the anchor assembly 300 is further configured toaccommodate at least a portion of the flexible member 324 therein. Forexample, as illustrated in FIG. 3A, the anchor assembly 300 includes apassageway 326 extending through the anchor inserter 304 and the anchortip 310. The passageway 326 includes a first pair of longitudinalchannels 326A, formed on respective inner surfaces of the anchor bodylumen 306A and outer shaft 314, extending from the anchor inserter 304to the distal end of the anchor body 306. The channels 326A are furtheraligned with complementary second pair of longitudinal channels 326B ofthe passageway 326 that are formed within the anchor tip 310 and extendfrom the proximal end to the distal end of the anchor tip 310.

The anchor tip 310 further includes a suture bridge 330. In theillustrated embodiment of FIG. 3A, the bridge 310 is interposed betweenlongitudinal channels 326B and positioned at about the distal terminusof the anchor tip 310. When the flexible member 324 is routed throughthe anchor assembly 300, it is bent around the suture bridge 330, withthe free limbs of the flexible member 324 extend proximally there-from,slidably received within the channels 326A, 326B.

In alternative embodiments, the configuration of the passageway 326 maybe modified. In one example, the configuration of the first channels326A may be changed, with the first channels 326A may formed on an outersurface of the inner shaft 316 (FIG. 3C) or within the inner shaft 316.In another example, the first channels 326A may be formed as a singlechannel within the inner shaft 316 (FIG. 3D).

In further embodiments, the configuration of the second channels withinthe anchor tip may be changed to completely hide the flexible memberwithin the anchor assembly, rather than routing the flexible memberoutside the distal end of the anchor tip. For example, the suture bridgemay be offset from the distal terminus of the anchor tip by a selecteddistance. The passageway may further include a transverse segment withinthe anchor tip, distal to the suture bridge and intersecting the pair ofchannels, recessing the bent portion of the flexible member within theanchor tip.

FIG. 3A further illustrates the anchor 302 mounted to the anchorinserter 304 prior to use. The inner shaft 316 extends through the outershaft 314 and the anchor body lumen 306A. The anchor tip 310 ispositioned distally of the anchor body 306 and the flexible member 324is routed through the passageway 326. In the embodiment of FIG. 3A, theproximal end of the anchor body 306 is placed into contact with thedistal end of the outer shaft 314 and the proximal end of the anchor tip310 is placed into contact with the distal end of the anchor body 306.However, in alternative embodiments, a gap may be present between atleast one of the proximal end of the anchor body and the distal end ofthe outer shaft and the proximal end of the anchor tip and the distalend of the anchor body.

In certain embodiments, the engagement mechanism of FIG. 1 discussedabove is omitted in the anchor assembly of FIG. 3A and, thus, the distalend of the inner shaft does not mechanically engage the anchor tip. Inother embodiments, the engagement mechanism of FIG. 1 may be included inthe anchor assembly of FIG. 3A and work in conjunction with the flexiblemember to proximally retract the anchor tip.

With further reference to FIGS. 4A-4B, the anchor assembly 300 isillustrated during use. A repair suture 404 is routed through the eyelet310B, where or more free limbs of the repair suture 404 extend outwardfrom the eyelet 310B. After the suture is positioned within the eyelet310B, at least a portion of the anchor 302 is inserted into a pre-formedbone hole within the patient's anatomy (not shown) using the anchorinserter 304. For example, the entire anchor may be inserted into thebone hole by pound in force directed to the anchor through the anchorinserter. During this insertion process, at least one of the free limbsof the repair suture are positioned such that they are impinged betweenthe anchor body and the walls of the bone hole. Similar to anchorassembly 100, the anchor 302 is supported by the inner shaft 316,providing mechanical durability that al lows the surgeon to move softtissue and/or bone with the anchor assembly 300. Furthermore, the anchortip 310 is useable by a surgeon as a probe to tactilely identify thelocation of the bone hole.

Until inserted into the bone hole, the components of the anchor assembly300 do not substantially move relative to one another. This isaccomplished by maintaining a light tension (proximally) on the freelimbs of the flexible member 324, sufficient to constrain axial motionof the anchor tip 310 and, in turn, the anchor body 306, but notsufficient to proximally actuate the flexible member 324 with respect tothe anchor body 306. However, once the anchor assembly 300 has beenplaced in the bone hole, the flexible member 324 is proximally actuated,as illustrated by arrow 406. As the flexible member 324 is routeddistally around the suture bridge 330, the anchor tip 310 also movesproximally in response to this motion. Initially, any gaps between theanchor tip, the anchor body, and the outer shaft are closed.Subsequently, the proximal end of the anchor tip is urged against thedistal end of the anchor body.

For example, in an embodiment (not shown), the proximal end of theflexible member is routed through a handle of the anchor inserter. Thisallows a user grasping the handle to proximally retract the flexiblemember.

As discussed above in regards to anchor assembly 100, the anchor tip 310and the anchor body 306 are configured such that, when the proximal endof the anchor tip 310 is urged against the distal end of the anchor body306, the proximal end of the anchor tip 310 deforms to accommodatereceipt of at least a portion of the distal end of the anchor body 306within the cavity 310A. Concurrently, the distal end of the anchor body306 exhibits little to no deformation.

For example, as illustrated in FIGS. 4A-4B, the eyelet 310B may definegeometric features such as wings 402 that deform about a hinge 402Aand/or a taper 322 in the proximal end of the anchor tip 310.Alternatively or additionally, at least the proximal end of the anchortip is formed from a material that substantially deforms, elastically orplastically, when urging the proximal end of the anchor tip against thedistal end of the anchor body.

In addition to the primary fixation between the anchor body 306 and thewalls of the bone hole, as discussed above, the anchor assembly 300 alsoprovides a secondary point of fixation between the anchor 302 and therepair suture 404. Notably, the repair suture 404 is impinged betweenthe proximal end of the anchor tip 310 and the distal end of the anchorbody 306.

In certain embodiments, the anchor assemblies 100, 300 may be providedas a kit, including the anchor and the anchor inserter pre-assembled.Such a configuration is beneficial for completely disposable systems,where the anchor inserter is discarded after being used to insert theattached anchor. In alternative embodiments, the anchor and anchorinserter may be provided separately and subsequently assembled. Such aconfiguration is beneficial for partially reusable systems, where theanchor inserter is saved and reconditioned for further use after beingemployed to insert an anchor that has been attached thereto.

The terms comprise, include, and/or plural forms of each are open endedand include the listed parts and can include additional parts that arenot listed. The term and/or is open ended and includes one or more ofthe listed parts and combinations of the listed parts.

One skilled in the art will realize the invention may be embodied inother specific forms without departing from the spirit or essentialcharacteristics thereof. The foregoing embodiments are therefore to beconsidered in all respects illustrative rather than limiting of theinvention described herein. Scope of the invention is thus indicated bythe appended claims, rather than by the foregoing description, and allchanges that come within the meaning and range of equivalency of theclaims are therefore intended to be embraced therein.

What is claimed is:
 1. A method of suture fixation; comprising:providing a suture anchor assembly comprising a suture anchor and ananchor inserter; the suture anchor comprising: an elongated anchor bodyhaving a lumen extending there-through between a proximal end and adistal end along a longitudinal axis; and an anchor tip having aproximal end and a distal end, the anchor tip including an eyeletextending transversely there-through and a cavity formed in the proximalend of the anchor tip, wherein the tip is separate from the anchor body;the anchor inserter comprising: a tubular outer shaft extending betweena proximal end and a distal end; and an inner shaft received within theouter shaft and the anchor body lumen; wherein the distal end of theinner shaft is mechanically engaged with the cavity of the anchor tip soas to position the anchor tip distally of the anchor body; routing asuture through the eyelet; inserting at least a portion of the anchorinto a bone hole using the anchor inserter; and proximally retractingthe inner shaft with respect to the anchor body and the outer shaft soas to urge the proximal end of the anchor tip against the distal end ofthe anchor body; wherein the proximal end of the anchor tip isdeformable to accommodate receipt of at least a portion of the distalend of the anchor body within the cavity upon being urged proximallyagainst the distal end of the anchor body.
 2. The method of claim 1,wherein the proximal end of the anchor tip deforms radially outward tocircumferentially overlie the portion of the distal end of the anchorbody received within the cavity.
 3. The method of claim 1, wherein theanchor tip further comprises a plurality of slots extending distallyfrom the proximal end of the anchor tip along the length of the cavitydefining a plurality of wings and wherein the plurality of wings deflectoutward to accommodate the portion of the distal end of the anchor bodyreceived within the cavity.
 4. The method of claim 1, further comprisingdisengaging the mechanical engagement of the inner shaft to the cavityafter deformation of the anchor tip to accommodate the portion of thedistal end of the anchor body received within the cavity.
 5. The methodof claim 1, wherein the mechanical engagement between the distal end ofthe inner shaft and the cavity is a break-away connection and whereindisengaging the mechanical engagement comprises severing the break-awayconnection.
 6. The method of claim 1, wherein the inner shaft does notengage the suture.
 7. The method of claim 1, wherein the proximal end ofthe anchor tip does not extend into the anchor body lumen upon beingurged proximally against the distal end of the anchor body.
 8. A sutureanchor assembly, comprising: a suture anchor, comprising: an elongatedanchor body having a lumen extending there-through between a proximalend and a distal end along a longitudinal axis, the anchor body furtherincluding a first pair of longitudinal channels formed on a surface ofthe lumen; an anchor tip having a proximal end and a distal end, theanchor tip being separate from the anchor body and including: an eyeletextending transversely there-through; a suture bridge extendingtransversely there-through; a cavity formed in the proximal end of theanchor tip; and a second pair of channels formed within the anchor tip,extending distally, from the cavity and adjacent to the suture bridge;and an anchor inserter, comprising: a tubular outer shaft extendingbetween a proximal end and a distal end; and an inner shaft slidablyreceivable within the outer shaft and the anchor body lumen; a flexiblemember routed through the anchor assembly with the anchor tip positioneddistally of the anchor body, wherein the flexible member bends aroundthe suture bridge and free limbs of the flexible member extending fromthe bend are slidably received within a passageway formed by the firstand second pair of channels; wherein the flexible member is proximallyretractable while routed through the anchor assembly so as to urge theproximal end of the anchor tip against the distal end of the anchorbody; and wherein the proximal end of the anchor tip is deformable so asto accommodate receipt of at least a portion of the distal end of theanchor body within the cavity upon being urged proximally against thedistal end of the anchor body.
 9. The anchor assembly of claim 8,wherein the proximal end of the anchor tip deforms radially outward tocircumferentially overlie the portion of the distal end of the anchorbody received within the cavity.
 10. The anchor assembly of claim 8,wherein the eyelet defines a plurality of wings in the proximal end ofthe anchor tip and wherein the plurality of wings deflect outward toaccommodate the portion of the distal end of the anchor body receivedwithin the cavity.
 11. The suture assembly of claim 8, wherein thesuture bridge is positioned at the distal terminus of the anchor tip andwherein the second pair of channels extend through the distal terminusof the anchor tip.
 12. The suture assembly of claim 8, wherein thesuture bridge is proximally distanced from the distal terminus of theanchor tip and wherein the passageway further includes a transverselyextending segment positioned distally of the suture bridge andintersecting the second pair of channels for routing the flexible memberaround the suture bridge within the anchor tip.
 13. A method of suturefixation, comprising: providing a suture anchor assembly comprising asuture anchor and an anchor inserter; the suture anchor comprising: anelongated anchor body having a lumen extending there-through between aproximal end and a distal end along a longitudinal axis, the anchor bodyfurther including a first pair of longitudinal channels formed on asurface of the lumen; an anchor tip having a proximal end and a distalend, the anchor tip being separate from the anchor body and including:an eyelet extending transversely there-through; a suture bridgeextending transversely there-through; a cavity formed in the proximalend of the anchor tip; and a second pair of channels formed within theanchor tip, extending is distally from the cavity and adjacent to thesuture bridge; and an anchor inserter, comprising: a tubular outer shaftextending between a proximal end and a distal end; and an inner shaftslidably received within the outer shaft and the anchor body lumen; aflexible member routed through the anchor assembly with the anchor tippositioned distally of the anchor body, wherein the flexible memberbends around the suture bridge and free limbs of the flexible memberextending from the bend are slidably received within a passageway formedby the first and second pair of channels; routing a repair suturethrough the eyelet; inserting at least a portion of the anchor into abone hole using the anchor inserter; and proximally retracting the innershaft and the free limbs of the flexible member with respect to theanchor body and the outer shaft so as to urge the proximal end of theanchor tip against the distal end of the anchor body; wherein theproximal end of the anchor tip is deformable so as to accommodatereceipt of at least a portion of the distal end of the anchor bodywithin the cavity upon being urged proximally against the distal end ofthe anchor body.
 14. The method of claim 13, wherein the proximal end ofthe anchor tip deforms radially outward to circumferentially overlie theportion of the distal end of the anchor body received within the cavity.15. The method of claim 13, wherein the eyelet defines a plurality ofwings in the proximal end of the anchor tip and wherein the plurality ofwings deflect outward to accommodate the portion of the distal end ofthe anchor body received within the cavity.
 16. The method of claim 13,further comprising removing the flexible member, the inner shaft, andthe outer shaft from the anchor.
 17. The method of claim 13, wherein thesuture bridge is positioned at the distal terminus of the anchor tip andwherein the second pair of channels extend through the distal terminusof the anchor tip.
 18. The method of claim 13, wherein the suture bridgeis proximally distanced from the distal terminus of the anchor tip andwherein the passageway further includes a transversely extending segmentpositioned distally of the suture bridge and intersecting the secondpair of channels for routing the flexible member around the suturebridge within the anchor tip.